Method of endoscopic suturing

ABSTRACT

An endoscopic suturing system and method are disclosed as are devices for use with the system and method such as a suture dispenser, a cinch device, and a tissue grasper. In one embodiment the suturing system includes a cap assembly arranged at the distal end portion of an endoscope or guide member, with the cap assembly including a rotatable needle holder. The needle holder is actuated through a transmission element extending outside the endoscope or guide member. A needle capture device may be inserted through a channel of the endoscope or guide member in order to capture a needle held in the needle holder when the needle holder is rotated so that the needle punctures tissue.

CLAIM OF PRIORITY

This application claims priority from provisional patent applicationU.S. 61/073,340 file Jun. 17, 2008 and from provisional patentapplication U.S. 61/162,249 filed Mar. 20, 2009, both of which arehereby incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a treatment device which can beinserted into a body through a natural orifice with an endoscope orother steerable guide member. The present invention may be used toperform suturing on the tissue of a mammal, whether human or not, andwhether or not alive, but is not limited thereto.

2. Description of the Related Art

U.S. Pat No. 7,344,545 (Olympus Corporation) discloses an endoscopicsuturing system having many embodiments to perform a surgical operation.This suturing system generally comprises an assembly having first andsecond arms which are actuatable by a push rod to rotatably approacheach other while one arm grasps tissue and the second arm drives acurved needle through the tissue. The system also includes a needlerecovery member requiring a rigid alignment with the curved needle arm.While this system affords the ability to grasp thick tissue, the tissuegrasping arm and the arrangement of the needle recovery member providesbulk to the system making it difficult to use in endoscopic procedures.

SUMMARY OF THE INVENTION

The present invention provides an endoscopic treatment device having astructure enabling a small profile for delivery while providing both alarge opening and closing angle and producing a large needle force forpiercing tissue to perform a surgical operation such as tissueapproximation and suturing within the body.

In accordance with an aspect of the present invention there is providedan endoscopic treatment device which is used to perform treatment in abody while being operated outside the body. The treatment devicecomprises a flexible member coupled to a proximal handle assembly foroperation outside of the body and a distal cap assembly where the capassembly is adapted to engage the distal end of an endoscope. Theflexible member is connected to a link mechanism and is actuated tocause a needle assembly having a needle holder arm and needle which arecoupled to the cap assembly to move in a direction to puncture tissueand a direction to be removed from tissue.

According to another aspect of the present invention there is providedan endoscopic treatment system for use with an endoscope having a capassembly adapted to be positioned at the distal end of an endoscopewhere the cap assembly has at least one mounting bracket which isfixedly attached. A transmission member with a flexible structure has adistal end portion that is inserted into a body and is capable of beingoperated outside the body by a proximal portion coupled to a handleassembly. A push rod is coupled to the distal end portion of thetransmission member. A connecting member having a needle holder arm iscoupled to the push rod and pivotally coupled to the mounting bracket. Aremovable needle is connected to the needle holder arm and is adapted topierce tissue. When the push rod is actuated by the transmission member,the connecting member moves the needle holder arm in a direction topierce tissue or in a direction to remove it from tissue. An elongateneedle capture device is positioned within the instrument channel of theendoscope and has a distal end adapted to receive and grasp the needleand a proximal end coupled to a handle assembly.

In accordance with another aspect of the present invention there isprovided a removable needle assembly having a needle tip member and aneedle base member. The needle tip member has a sharpened end which isadapted to pierce tissue and a hollow end to receive the needle basemember. The needle tip member also includes an aperture which may takethe form of a longitudinal slot through the wall adjacent the hollow endwhich is adapted to allow suture to extend there from. The needle basemember has a first end which is adapted to engage the hollow end of theneedle tip member and a second end which is adapted to removably engagea needle holder arm. The needle base member further includes a stopmember which when coupled with the needle holder arm limits the depth towhich the needle base is inserted into the needle holder arm. Thecoupling engagement of needle tip member and the first end of the needlebase member are adapted to secure a length of suture material to theneedle assembly and allow it to extend through the aperture adjacent thehollow end of the needle tip member.

In accordance with still another aspect of the present invention thereis provided a needle clip assembly having first and second ends where aneedle tip adapted for piercing tissue is positioned at the first endand a tissue stop member is positioned at the second end. The needleclip assembly has a constrained first configuration and an unconstrainedsecond configuration where the needle clip assembly is resilientlybiased to move from the first configuration to the second configuration.The constrained first configuration may take the form of a generallystraightened elongate member. The unconstrained second configuration maytake the form of a loop, helix or substantially closed loop form.

In accordance with yet another aspect of the present invention there isprovided an endoscopic treatment system for use with an endoscope havinga cap assembly adapted to be positioned at the distal end of anendoscope where the cap assembly has two pair of fixedly attachedmounting brackets. A transmission member with a flexible structure has adistal end portion that is inserted into a body and is capable of beingoperated outside the body. A push rod is coupled to the distal endportion of the transmission member. A connecting member having a needleholder arm is coupled to the push rod and pivotally coupled to the outerpair of mounting brackets. A link member having two ends is pivotallycoupled to the inner pair of mounting brackets at one end and pivotallycoupled to the needle holder arm at the other end. A removable needle isconnected to the needle holder arm and is adapted to pierce tissue. Whenthe push rod is actuated by the transmission member, the connectingmember moves the needle holder arm in a direction to pierce tissue or adirection to remove it from tissue. An elongate needle capture device ispositioned within the instrument channel of the endoscope having aproximal handle and a distal end adapted to receive and grasp theneedle.

In accordance with yet another aspect of the present invention there isprovided a combination handle assembly adapted to operate the movementof the transmission member thereby opening and closing the needle armand adapted to operate the needle capture device to thereby grasp andrelease the needle. The handle assembly includes a handle main bodycoupled to an endoscope channel coupling which is adapted to engage theinstrument channel of an endoscope. An elongate needle capture deviceincludes a proximal housing which is removably coupled to the handlemain body and a distal end is which positioned through the endoscopechannel coupling into the instrument channel of an end. An actuatabletrigger lever is coupled to handle main body and operates thetransmission member to axially advance or retract the transmissionmember.

In accordance with another aspect of the present invention there isprovided an endoscopic treatment system that further includes a tissuegrasping member. The tissue grasping member takes the form of anelongate member having proximal and distal ends and is positioned with achannel of an endoscope. The distal end of the tissue grasping membermay take the form of a helix or tapered spiral in which rotation of thehelix when at a desired site adjacent tissue, causes the helix tosubstantially engage the tissue and allow the tissue to be retracted.

In accordance with still another aspect of the present invention thereis provided an endoscopic treatment system that further includes atissue grasping member. The tissue grasping member takes the form of anelongate member having proximal and distal ends and is positioned with achannel of an endoscope. The distal end of the tissue grasping membermay take the form of a pair of jaws such that when at a desired siteadjacent tissue, operation of the jaws causes the jaws to substantiallyengage the tissue and allow the tissue to be retracted.

In accordance with another aspect of the present invention there isprovided an endoscopic treatment device which is used to performtreatment in a body while being operated outside the body. The treatmentdevice comprises a flexible member coupled to a proximal handle assemblyfor operation outside of the body and a distal cap assembly where thecap assembly is adapted to engage the distal end of an endoscope. Thecap assembly includes an elongate channel lock member having one endwhich is fixedly attached to the cap assembly and extends through thechannel of an endoscope and is removably secured to the proximal end ofthe endoscope channel. The channel lock member may take the form of asmall diameter flexible wire assembly or wire braid assembly.

In accordance with yet another aspect of the present invention there isprovided an endoscopic suturing system for use with an endoscope havinga cap assembly adapted to be positioned at the distal end of anendoscope where the cap assembly defines mounting locations. Atransmission member with a flexible structure has a distal end portionthat is inserted into a body and is capable of being operated outsidethe body. A push member is optionally coupled to the distal end portionof the transmission member. A link member having a geared portion iscoupled to the push member or the transmission member and pivotallycoupled at a first mounting location. A connecting member having ageared portion and a needle holding arm at one end is pivotally coupledat a second mounting location such that the geared portions of the linkmember and the connecting member intermesh.

In accordance with another aspect of the present invention there isprovided an endoscopic suturing system for use with an endoscope havinga cap assembly adapted to be positioned at the distal end of theendoscope where the cap assembly includes an elongate needle guard. Theneedle guard generally extends from a base of the cap in a directiondistal to the end of the endoscope. Preferably the needle guard extendsin a distal direction parallel to the axis of the endoscope. The needleguard is adapted to prevent tissue from inadvertently contacting theneedle tip while the needle tip is in an open position and the tissue isbeing positioned for suturing.

In accordance with another aspect of the present invention there isprovided an endoscopic suturing system for use with an endoscope havinga cap assembly adapted to be positioned at the distal end of theendoscope where the cap assembly includes an elongate channel guard. Thechannel guard generally extends from a base of the cap in a directiondistal to the end of the endoscope and is coaxial with the endoscopechannel which used by the needle capture device. The channel guard isadapted to aid in suturing by positioning tissue a sufficient distanceaway from the end of the endoscope channel allowing for bettervisualization and providing a surface to support the tissue during thesuturing operation. Preferably, the distal end of the channel guard isinclined to provide a plane which is generally perpendicular to theneedle tip as the needle tip intersects the plane along the needlesuturing path. Preferably, the minimum length that the channel guardextends from the cap is related to the field of view from the endoscopesuch that minimum length allows sufficient tissue to be visualized whenthe tissue is placed in a position for suturing.

In accordance with another aspect of the present invention there isprovided an endoscopic treatment device which is used to performtreatment in a body while being operated outside the body. The treatmentdevice comprises a flexible member coupled to a proximal handle assemblyfor operation outside of the body and a distal cap assembly where thecap assembly is adapted to engage the distal end of an endoscope. Thecap assembly includes an elongate channel lock member having one endwhich is removably secured to the cap assembly and extends through thechannel of an endoscope and is removably secured to the proximal end ofthe endoscope channel by a tensioning assembly. The channel lock membermay take the form of a small diameter flexible wire assembly or wirebraid assembly. Preferably, the channel lock member includes retainingmembers fixedly secured to each end. The tensioning assembly includes abayonet lock fitting adapted to engage a bayonet prong on the endoscope,a housing member, a rotatable wheel member having a tab member and atensioner member. The proximal end of the channel lock member is securedto the tab member of the rotatable wheel such that rotation of the wheelapplies a preset tension to the channel lock member. The housing memberof the tensioning assembly in conjunction with the tensioner member,preferably formed of a spring, maintains the tension on the channel lockmember by resisting compression during normal bending operation of theendoscope.

According to another aspect of the endoscopic treatment system of thepresent invention there is provided a cinch system including a cinchdelivery device and a cinch device. The cinch delivery device takes theform of an elongate tubular member having proximal end coupled to ahandle assembly and a distal end. The distal end of the cinch deliverydevice is removably coupled to the cinch device. The cinch device has ahousing that incorporates a suture capture hook at is distal end forcapturing suture that has been placed through tissue. A cinch plug ispositioned within the cinch housing and is movable from a first suturenon-retaining position to a second suture retaining position forsecuring suture in a fixed position by operating the handle assembly.Once suture has been secured by the cinch plug in the cinch housing thehandle assembly may be operated to uncouple the cinch device from thecinch delivery tool.

According to still another aspect of the present invention, there isprovided a suturing method using an endoscopic suturing system. Thismethod comprises the steps of:

(1) inserting a guide tube and/or endoscope into a body with a suturingdevice coupled to the endoscope and or guide tube;

(2) opening a needle arm of the suturing device having a removableneedle;

(3) pushing the needle against tissue at a desired suture site;

(4) closing the needle arm of the suturing device;

(5) piercing the tissue with the needle;

(6) recovering the needle by using a needle capture device;

(7) removing the needle from the tissue;

(8) opening the needle arm to remove it from tissue;

(9) closing the needle arm; and

(10) removing the suturing device from the body.

According to yet another aspect of the present invention, there isprovided a suturing method using an endoscopic suturing system includinga tissue grasper. This method comprises the steps of:

(1) inserting a guide tube into a body;

(2) inserting a suturing device coupled to an endoscope into the guidetube and into the body;

(3) opening a needle arm of the suturing device having a removableneedle;

(4) engaging a tissue adjacent a desired suture site using a tissuegrasper;

(5) pushing the needle against tissue at a desired suture site;

(6) closing the needle arm of the suturing device;

(7) piercing the tissue with the needle;

(8) recovering the needle by using a needle capture device;

(9) removing the needle from the tissue;

(10) opening the needle arm to remove it from tissue;

(11) releasing the tissue from the tissue grasper;

(12) closing the needle arm; and

(13) removing the suturing device from the body.

According to another aspect of the present invention, there is provideda suturing method of performing a running stitch using an endoscopicsuturing system. This method comprises the steps of:

(1) inserting a guide tube into a body;

(2) inserting a suturing device coupled to the endoscope into the guidetube and inserting the suturing device into the body;

(3) opening a needle arm of the suturing device having a removableneedle;

(4) pushing the needle against tissue at a desired suture site;

(5) closing the needle arm of the suturing device;

(6) piercing the tissue with the needle;

(7) recovering the needle by using a needle capture device;

(8) removing the needle from the tissue;

(9) opening the needle arm to remove it from tissue;

(10) closing the needle arm;

(11) inserting the needle into the needle arm endoscopically using theneedle capture device;

(12) performing steps (3) through (11) as needed.

According to still yet another aspect of the present invention there isprovided a method of securing tissue using an endoscopic suturing systemincluding a resilient pre-biased needle clip and a tissue grasper. Thismethod comprises the steps of:

(1) inserting a guide tube into a body;

(2) inserting a suturing device coupled to the endoscope into the guidetube and inserting the suturing device into the body;

(3) opening a needle holding arm of the suturing device having aremovable needle clip;

(4) engaging a tissue adjacent a desired suture site using a tissuegrasper

(5) pushing the needle clip against tissue at a desired suture site;

(6) closing the needle holding arm of the suturing device;

(7) piercing the tissue with the needle clip;

(8) grasping the needle clip tip using a needle capture device;

(9) opening the needle holding arm to remove it from tissue;

(10) releasing the needle clip from the needle capture device

(11) releasing the tissue from the tissue grasper;

(12) closing the needle holding arm; and

(13) removing the suturing device from the body.

Advantages of the invention will be set forth in the description whichfollows, and in part will be obvious from the description, or may belearned by practice of the invention. Advantages of the invention may berealized and obtained by means of the instrumentalities and combinationsparticularly pointed out hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the invention, andtogether with the general description given above and the detaileddescription of the embodiments given below, serve to explain theprinciples of the invention.

FIG. 1 is an illustrative view showing an endoscopic suturing systemwith endoscope system according to a first embodiment of the presentinvention;

FIG. 2 is an enlarged view of the proximal portion of an endoscope andan endoscopic suturing system shown in FIG. 1;

FIG. 3 is a perspective enlarged view of the distal end of an endoscopicsuturing system according to an embodiment of the present inventionwhere the actuating arm of the suturing device is closed;

FIG. 4 is a perspective enlarged view of the distal end of an endoscopicsuturing system according to an embodiment of the present inventionwhere the actuating arm of the suturing device is open;

FIG. 5 is another perspective enlarged view of the distal end of anendoscopic suturing system according to an embodiment of the presentinvention where the actuating arm of the suturing device is open;

FIG. 6 is a perspective enlarged view of the cap assembly of anendoscopic suturing system according to an embodiment of the presentinvention where the actuating arm of the suturing device is closed;

FIG. 7 is an illustrative view of a needle assembly for use with anendoscopic suturing device according to an embodiment of the presentinvention;

FIG. 8 is an exploded view of a needle assembly of FIG. 7;

FIG. 9 is an illustrative view of a needle assembly for use with anendoscopic suturing device according to another embodiment of thepresent invention.

FIG. 10 is a view of an endoscopic clip for use with an endoscopicsuturing system according to an embodiment of the present invention;

FIG. 11 is a view of the preferentially biased resilient endoscopic clipof FIG. 10 when unconstrained.

FIG. 12 is a view of an endoscopic clip for use with an endoscopicsuturing system according to another embodiment of the presentinvention;

FIG. 13 is a view of the preferentially biased resilient endoscopic clipof FIG. 12 when unconstrained;

FIG. 13A is a view of the preferentially biased resilient modifiedendoscopic clip of FIG. 13 when unconstrained and having a coil thatextends over the sharp tip;

FIG. 14 is a view of the helical tissue grasper;

FIG. 15 is an enlarged view of the distal end of the helical tissuegrasper;

FIG. 16 is a top view of a cinch device and cinch delivery device;

FIG. 17 is a side view of a cinch device and cinch delivery device;

FIG. 18 is an enlarged exploded view of the distal end of the cinch andcinch delivery device;

FIG. 19 is an enlarged view of the cinch device in an openconfiguration;

FIG. 20 is an enlarged view of the cinch device in a closedconfiguration;

FIG. 21 is a sectional view of an endoscopic guide tube;

FIG. 22 is a partial sectional view of an endoscopic suturing systemdisposed within the lumen of an endoscopic guide tube;

FIG. 23 is a partial sectional view of an endoscopic suturing systemextending from the distal end of an endoscopic guide tube;

FIG. 24 through FIG. 34 illustrate steps in a surgical suturingprocedure using an endoscopic suturing system according to an embodimentof the present invention wherein FIG. 24 is a view of a step in which aan endoscopic suturing device is positioned adjacent a wound at adesired treatment location;

FIG. 25 is a view of a step in which a tissue grasper is extendedadjacent a wound at a desired treatment location;

FIG. 26 is a view of a step in which a tissue grasper engages tissue andis slightly retracted to bring tissue closer to the endoscope;

FIG. 27 is a view of an alternative step in which a tissue grasperengages tissue and is substantially retracted to bring tissue in contactwith the endoscope;

FIG. 28 is a view of a step in which the needle pierces tissue;

FIG. 29 is a view of a step in which the needle holder arm is removedfrom the tissue depositing a suture through the tissue;

FIG. 30 is a view of a step in which the tissue grasper disengages thetissue;

FIG. 31 is a view of a step in which the needle is reloaded into theneedle holder arm;

FIG. 32 is a view of a step in which a cinch device captures suture;

FIG. 33 is a view of a step in which the suture is tightened using thecinch device to thereby close the wound;

FIG. 34 is a view of a cinch device released from the cinch deliverydevice;

FIG. 35 through FIG. 38 illustrate steps in a surgical suturingprocedure using an endoscopic suturing system according to anotherembodiment of the present invention wherein FIG. 35 is a view of a stepin which a an endoscopic suturing device has delivered a needle throughtissue at a desired treatment location;

FIG. 36 is a view of a step in which a cinch device captures suture;

FIG. 37 is a view of a step in which the suture is tightened using thecinch device to thereby close the wound;

FIG. 38 is a view of a cinch device released from the cinch deliverydevice;

FIG. 39 through FIG. 42 illustrate steps in a surgical suturingprocedure using an endoscopic suturing system according to yet anotherembodiment of the present invention wherein FIG. 39 is a view of a stepin which an endoscopic suturing device having a needle clip ispositioned at a desired treatment location;

FIG. 40 is a view of a step in which the needle clip pierces tissue;

FIG. 41 is a view of a step in which the needle holder arm is removedfrom the tissue depositing the needle clip through the tissue;

FIG. 42 is a view of a step in which the tissue grasper disengages thetissue and the needle clip close the wound;

FIG. 43 is an illustrative view showing an endoscopic suturing systemwith a channel lock member according to another embodiment of thepresent invention;

FIG. 44 is a perspective enlarged view of the cap assembly of anendoscopic suturing system according to an embodiment of the presentinvention where the actuating arm of the suturing device is closed;

FIG. 45 is a perspective enlarged view of the cap assembly of anendoscopic suturing system according to an embodiment of the presentinvention where the actuating arm of the suturing device is open;

FIG. 46 is a perspective enlarged exploded view of the cap assembly ofan endoscopic suturing system according to an embodiment of the presentinvention;

FIG. 47 is another perspective enlarged view of the cap assembly of anendoscopic suturing system according to an embodiment of the presentinvention where the actuating arm of the suturing device is closed;

FIG. 48 is yet another perspective enlarged view of the cap assembly ofan endoscopic suturing system according to an embodiment of the presentinvention where the actuating arm of the suturing device is closed;

FIG. 49 is still another perspective enlarged view of the cap assemblyof an endoscopic suturing system according to an embodiment of thepresent invention;

FIG. 50 is still yet another perspective enlarged view of the capassembly of an endoscopic suturing system according to an embodiment ofthe present invention;

FIG. 51 is perspective enlarged view of the channel lock tensionerassembly in a first configuration according to an embodiment of thepresent invention;

FIG. 52 is perspective enlarged view of the channel lock tensionerassembly in a second configuration according to an embodiment of thepresent invention;

FIG. 53 is an illustrative view of a needle assembly according to anembodiment of the present invention;

FIGS. 54A through 54C illustrate steps in assembling the components of aneedle assembly according to an embodiment of the present invention;

FIG. 55 is an illustrative view of a needle capture device according toan embodiment of the present invention;

FIGS. 56A and 56B are enlarged partial section views of the distal endof a needle capture device, where FIG. 56A illustrates the needlecapture assembly in a normally closed configuration and FIG. 56Billustrates the needle capture assembly in an open configuration;

FIG. 57 is an enlarged partial section view of the needle captureassembly interlockingly engaging a needle assembly according to anembodiment of the present invention;

FIG. 58 is a perspective view of a handle assembly of an endoscopicsuturing system according to an embodiment of the present invention;

FIG. 59A is a cross-sectional view of the handle assembly of FIG. 58 ina closed position with the handle assembly of the capture assemblylocked in position therein;

FIG. 59B is a perspective view of the arrangement of FIG. 59A;

FIG. 59C is a perspective view of the handle assembly of FIG. 58 in anopen position and with the handle assembly of the capture assemblylocked in position therein;

FIG. 60A is a perspective view of a molded suture dispenser including aremovable needle shield tab;

FIG. 60B is a perspective view of the suture dispenser where the needleshield tab has been removed to provide access to the needle retainingmember;

FIG. 60C is an exploded perspective view illustrating the components ofthe molded suture dispenser;

FIG. 61A is an enlarged perspective view of the needle retaining member;

FIG. 61B is an enlarged partial cross-sectional view of the needleretaining member securing the removable needle assembly;

FIG. 62A is a perspective view illustrating the needle capture deviceengaging the suture dispenser;

FIG. 62B is an enlarged partial cross-sectional view of the needlecapture assembly interlockingly engaging the removable needle assemblypositioned within the needle retaining member of the suture dispenser;

FIG. 63 through FIG. 69 illustrate steps in a surgical suturingprocedure using an endoscopic suturing system according to anotherembodiment of the present invention wherein FIG. 63 is a view of a stepin which a an endoscopic suturing device is positioned adjacent a woundat a desired treatment location;

FIG. 64 is a view of a step in which a tissue grasper is extendedadjacent a wound at a desired treatment location;

FIG. 65 is a view of a step in which a tissue grasper engages tissue andis slightly retracted to bring tissue closer to the endoscope;

FIG. 66 is a view of an alternative step in which a tissue grasperengages tissue and is substantially retracted to bring tissue in contactwith the endoscope;

FIG. 67 is a view of a step in which the needle partially piercestissue;

FIG. 68 is a view of a step in which the needle completely piercestissue;

FIG. 69 is a view of a step in which the needle holder arm is removedfrom the tissue depositing a suture through the tissue;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in FIG. 1 an endoscope system 10 which comprises an endoscope12, a video display unit 14, an image processing device 16, a lightsource 17, a suction device 18 is used with and an endoscopic suturingdevice 20 as part of an endoscopic treatment system according to oneembodiment of the present invention. FIG. 2 and FIG. 3 illustraterespectively the proximal and distal portions of endoscope 12 andendoscopic suturing device 20. The endoscopic suturing device 20 has anoperable handle 22 which is removably coupled to endoscope 12 at a firstinstrument channel 24. A tissue grasper 26 which is used to gathertissue is shown positioned within a second instrument channel 28 ofendoscope 12. The endoscopic suturing device 20 includes an elongateneedle capture device 30 which is removably coupled to handle 22 andextends to the distal end of endoscope 12 slidably positioned withininstrument channel 24. The endoscopic suturing device 20 is operated byhandle 22 which is proximally coupled to transmission assembly 32 whichextends distally along the exterior of insertion tube 34 to the distalend 36 of endoscope 12. The transmission assembly is coupled at itsdistal end to a cap assembly 38 which is positioned over the distal end36 of endoscope 12. FIG. 3 shows the distal end 40 of needle capturedevice 30 and the distal end helical tip 42 of tissue grasper 36extending from instrument channels 24 and 28 respectively. Positionedadjacent to needle capture device distal end 40 is needle assembly 44which is connected to suture 46. Needle assembly 44 is removablyinserted into needle holder arm 48. Transmission assembly 32 comprisesan outer sheath 50 which is preferably formed of a flexible coil and apush rod 52 positioned within the lumen and extending from the distalend of outer sheath 50. Outer sheath 50 is fixedly secured to capassembly 38. Push rod 52 is coupled to a connecting member 54 via apivot pin 56, and optionally via a push member 52 a which may couple therod 52 and the pivot pin 56. The connecting member 54 is also connectedto a pair of outer mounting brackets 58 via pivot pin 60. The mountingbrackets 58 are fixedly attached to cap assembly 38. A pair of innermounting brackets 62 are fixedly attached to the cap assembly 38 andpivotally connected to one end of a link member 64 via pivot pin 66. Theother end of link member 64 is connected to the needle holder arm 48 viapivot pin 68. Needle holder arm 48 is coupled to connecting member 54via pivot pin 69.

As shown in FIG. 3, FIG. 4, and FIG. 5, the pivotable connections ofconnecting member 54 and link member 64 to outer and inner mountingbrackets 58 and 62 respectively, allow the rotation of needle holder arm48 when push rod 52 is axially advanced or retracted. In FIG. 4, the capassembly 38 is shown in an open configuration with push rod 52 advanced(compare FIG. 3 where the cap assembly is in a closed configuration withpush rod 52 retracted). FIG. 5 shows the endoscopic suturing device 20in an open configuration and from another angle where outer and innerpairs of mounting brackets 58 and 62 are more visible.

FIG. 6 shows a view of cap assembly 38 uncoupled from an endoscope. Capassembly 38 includes a fixedly attached insert guide 70 coupled to aflexible channel lock 72. Insert guide 70 is a tubular projection fromcap assembly 38 and is adapted to be positioned within the lumen of anendoscope instrument channel at its distal end. The elongate flexiblechannel lock 72 extends from the insert guide 70 through an instrumentchannel and is secured to the proximal end of the instrument channel.The channel lock 72 ensures that the cap assembly 38 does notinadvertently disengage from the distal end of the endoscope. Preferablychannel lock 72 takes the form of a small diameter single or multistranded wire or cable formed primarily of metals or polymers.Additionally the small diameter of channel lock 72 allows room for otherinstruments to be positioned within the instrument channel of theendoscope.

FIG. 7 illustrates needle assembly 44 which comprises a needle body 74,a needle tip 76 and suture 46. The suture 46 may be formed of anymaterials commonly available for surgical suture such as nylon,polyolefins, PLA, PGA, stainless steel, nitinol and others. FIG. 8 showsa detailed exploded view of two components of needle assembly 44. Needletip 76 has a sharp distal end and a hollow proximal end having a sutureslot 78 through the side wall. Needle body 74 has a rounded or blunttapered proximal end 74 a adapted to fit within the needle holder armwith the proximal end 74 a presenting a shoulder 79 between end 74 a andthe remainder of the needle body 74. A distal end 74 b of the needlebody 74 has a suture slot 80 adapted to concentrically engage needle tip76. Flexible suture material is positioned on the distal end of needlebody 74 extending through the aligned suture slots 78 and 80. The needletip 76 and needle body 74 are formed from suitable biomaterials and maybe made from polymers such as nylon, PEEK, PLA, PGA, PLGA or metals suchas stainless steel, nitinol or titanium. The components may be joinedusing standard joining techniques such as thermal bonding, ultrasonicwelding laser welding, adhesives or mechanical crimping. FIG. 9illustrates an alternative needle assembly 82 having a needle tail 84and a needle tip 86. Needle tip 86 has a sharpened distal end, a sutureaperture 88 and a hollow proximal end which is adapted to receive needletail 84. Suture 90 is positioned within the hollow end of needle tip 86and extends through aperture 88. Needle tail 84 and suture 90 aresecured in the hollow end of needle tip 86 using any of theaforementioned joining techniques. Needle tail 84 is preferably formedin a straightened shape and of a resilient material such as nitinol.When needle tail 84 is placed in a curved needle holder arm the needletail bends and applies a force to the inner wall of the needle holderarm maintaining the needle assembly 82 securely in place.

FIG. 10 through FIG. 13A illustrate alternate versions of needleassemblies for use in closing tissue defects. FIG. 10 shows a needleclip 92 in a straightened configuration having a body portion 94 aproximal beaded end 96 and a piercing tip 98. The needle clip 92 ispreferably formed of nitinol or other resilient material and biased intoa generally circular shape. Needle clip 92 may be constrained in agenerally straightened configuration but when unconstrained transitionsto its biased generally circular configuration as shown in FIG. 11. FIG.12 shows an alternate needle clip 100 having a proximal bead 102, apiercing tip 104, an outer coil covering 106, and a body portion 108connecting the proximal and distal ends. The needle clip 100 alsoincludes a securing member 110 to fixedly attach at least a portion ofcoil 106 to body portion 108. The needle clip 100 is preferablycomprised of nitinol or other resilient material and is biased into agenerally circular shape. Needle clip 100 may be constrained in agenerally straightened configuration but when unconstrained transitionsto its biased generally circular configuration as shown in FIG. 13. Thecoil 106 may be formed of suitable biomaterials such as polymers ofnylon, polyester, PEEK, PLA, PGA, PLGA or metals such as stainlesssteel, nitinol, titanium or platinum. The coil 106 provides increasedsurface area for tissue in growth and encapsulation as well asdistributing the force placed on tissue when closing a tissue defect.FIG. 13A shows a needle clip 100 in which the coil 106 extends over thesharp piercing tip thereby shielding the tip from inadvertent damage tosurrounding tissue.

FIG. 14 shows the tissue grasper 26 which has a proximal handle 108, anelongate shaft member 110 and a helical tip 42. Shaft member 110 isformed of a wire or multi-stranded cable or any torque transmittingconfiguration that provides flexibility which does not impede thesteering capabilities of the endoscope. FIG. 15 shows an enlarged viewof the distal end of tissue grasper 26. Shaft member 110 is coupled tohelical tip 42 by tip coupling member 112. Tip coupling member 112 maybe fixedly joined to helical tip 42 and shaft member 110 by any of theaforementioned joining techniques.

FIG. 16 and FIG. 17 show a cinch deployment system 114 for securingsuture placed at a tissue defect site. The cinch deployment system 114comprises a cinch assembly 116 and a cinch delivery device 118. Thecinch delivery device 118 has an elongate flexible tubular shaft 120which is removably coupled at its distal end to cinch assembly 116 andfixedly attached at its proximal end to handle member 122. Handle member122 includes a slidable finger ring assembly 124 and a thumb ring 126.Slidably disposed within the lumen of tubular shaft 120 is push rod 128.Push rod 128 extends from the distal end of tubular shaft 120 to theproximal end of tubular shaft 120 and is coupled to the slidable fingerring assembly 124 with fixation screw 130, such that movement of thefinger ring assembly relative to the thumb ring 126 causes the axialmovement of push rod 128 within the lumen of tubular shaft 120. Apartially exploded view of the distal end of the cinch deployment system114 is shown in FIG. 18. As depicted, push rod 128 extends from tubularshaft 120 and through latch assembly 129. Latch assembly 129 is fixedlyattached to tubular shaft 120 and has two latch arms 132 with latch tabs134 at their distal ends. Latch arms 132 are biased inwardly towards thecentral longitudinal axis of tubular shaft 120. Latch assembly 129 ispositioned within the lumen of a latch coupling 136 and is fixedlysecured. Latch coupling 136 is configured at its distal end to engagewith the proximal end of cinch 116 such that the latch arms 132 extendwithin the proximal lumen of cinch 116 and when push rod 128 ispositioned within latch assembly 129 the latch arms 132 are forcedoutwardly such that the latch tabs 134 locking engage the cinch tabapertures 138. When push rod 128 is axially retracted from latchassembly 129 the latch arms 132 move inwardly towards their biasedconfiguration causing latch tabs 134 to release their locking engagementwith cinch tab apertures 138 to thereby release the cinch assembly 116.FIG. 19 illustrates the cinch assembly 116 in an open configuration.Cinch assembly 116 has a tubular housing member 139 having cinch tabapertures 138 located at its proximal end and a suture hook 140 fixedlyattached at its distal end. A securing clasp 142 is slidably positionedwithin the lumen of housing member 139. A retention tab 144 ispreferably formed from the wall of housing member 139 and biasedinwardly towards the central axis at of housing member 139 at its distalend. When suture has been captured by suture hook 140 the suture may besecured within cinch assembly 116 by advancing push rod 128 such thatsecuring clasp 142 extends from housing member 139 and engages suturehook 140. With securing clasp 142 in extended configuration retentiontab 144 moves to its inwardly biased configuration restricting theproximal movement of the securing clasp 142 thereby fixing the suture inplace.

FIG. 21 illustrates a guide tube 146 for use in an endoscopic procedure.Guide tube 146 has a proximal end 148 including a lumen 150 that extendsto the distal end 152. Generally a guide tube 146 is positioned in apatient to provide a conduit to a desired location while protecting thesurrounding tissue from inadvertent damage. As shown in FIG. 22 and FIG.23 show a guide tube 146 with an endoscopic suturing device 20positioned in the lumen 150. Once the guide tube 146 is positioned at adesired treatment location within the body the distal end of theendoscopic suturing device 20 may be extended beyond the distal end ofthe guide tube 146.

FIG. 24 through FIG. 34 depicts a method of performing a suturingoperation using an endoscopic suturing device 20 of the presentinvention. As shown in FIG. 24, the endoscopic suturing device 20 ispositioned adjacent tissue 154 which has a tissue defect 156 to beclosed. The endoscopic suturing device 20 is in an open configuration.FIG. 25 shows the tissue grasper 26 extended from the endoscopeinstrument channel such that helical tip 42 is adjacent tissue defect156. Rotation of the tissue grasper 26 causes the helical tip 42 tosecurely engage the tissue 154 adjacent to the tissue defect 156. Thetissue 154 may be brought closer to the endoscope by slightly retractingthe tissue grasper 26 into the instrument channel of the endoscope asshown in FIG. 26. The degree of tissue retraction correlates to the sizeand location of the stitch. For instance, to have a larger amount oftissue sutured, the tissue 154 may be brought into contact with theendoscope by the tissue grasper as shown in FIG. 27. The needle holderarm 48 is actuated to move to a closed position causing the needleassembly 44 to pierce tissue 154. The suture 46 is pulled through thetissue as shown in FIG. 28. The control over the amount of tissueretracted allows the physician the ability to perform a partialthickness stitch within the wall of a tissue or a full thickness stitchwhich extends through a wall of tissue. The needle capture devicecaptures the needle assembly 44 by gripping it at shoulder 79 (FIG. 7)and removes it from the needle holder arm 48 (not shown). FIG. 29 showsthe needle holder arm 48 moved to an open configuration and removed fromtissue 154. Suture 46 remains through the tissue. FIG. 30 shows thelengthening of the suture 46 through the tissue 154 by retracting theendoscopic suturing device 20 while retaining the needle assembly 44within the needle capture device. FIG. 31 shows the needle holder arm 48moved to a closed configuration and needle assembly 44 reinserted intothe needle holder arm 48 by advancing the needle capture device if thephysician wishes to make another stitch. If the physician does not wishto make another stitch, the needle assembly with suture can be retractedthrough the endoscope channel and with both ends of the suture, a knotcan be tied and pushed down the endoscope channel to the treatment siteto secure the tissue. Alternatively, the suture can be secured using acinch deployment system. As shown in FIG. 32 a cinch assembly 116 and acinch delivery device 118 may be used to capture the suture 46. Thesuture may be pulled tight to securely close the tissue defect 156. Oncethe tissue defect 156 is sufficiently closed the cinch assembly 116 maybe moved to a closed configuration, thereby securing the suture 46 asshown in FIG. 33. The cinch delivery device 118 can release the cinchassembly 116 as shown in FIG. 34 and the suture 46 may then be cut usingany standard cutting means such as scissors. It is contemplated that thecinch assembly may incorporate cutting means after securing the suture.

FIG. 35 through FIG. 38 shows another method of closing a tissue defectand securing the suture. FIG. 35 shows the endoscopic suturing device 20having delivered a needle assembly 44 (shown schematically) and suture46 through tissue 154 adjacent a tissue defect 156 where the needleassembly 44 is resting adjacent the surface of tissue 154. FIG. 36 showsa cinch deployment system having a cinch assembly 116 and a cinchdelivery device 118 that has grasped a portion of suture 46. The sutureis pulled tight to close the tissue defect 156 while the needle assemblyprevents the end of suture 46 from pulling through the tissue 154. Oncethe tissue defect 156 is sufficiently closed the cinch assembly 116 maybe moved to a closed configuration, thereby securing the suture 46 asshown in FIG. 37. The cinch delivery device 118 can release the cinchassembly 116 as shown in FIG. 38 and the suture 46 may then be cut usingany standard cutting means such as scissors.

FIG. 39 through FIG. 42 shows still another method securely closing atissue defect. FIG. 39 shows an endoscopic suturing device 20 having anopen configuration and a needle clip 100 having a proximal bead 102 anda piercing tip 104 positioned in needle holder arm 48. The helical tip42 of the tissue grasper 26 has engaged tissue 154 adjacent to thetissue defect 156 and retracted the tissue towards the endoscope. FIG.40 shows the needle holder arm 48 in a closed configuration positionedthrough the tissue with the piercing tip 104 of needle clip 100 havingpierced and exited the tissue. FIG. 41 shows the needle capture devicegrasping the piercing tip of the needle clip 100 with the needle holderarm 48 in an open configuration and removed from tissue 154. Theproximal bead 102 of needle clip 100 is positioned adjacent the tissuesite initially pierced by the piercing tip. FIG. 42 shows the release oftissue 154 from the tissue grasper and the resilient needle clip 100taking its pre-biased generally circular shape thereby closing thetissue defect 156. As can be appreciated, the application of a tissuesealant or adhesive may be used to aid in the closing the tissue defect.

FIG. 43 shows an endoscopic suturing device 320 according to anotherembodiment of the present invention. Endoscopic suturing device 320includes a cap assembly 322 which is adapted to engage with the distalend of an endoscope, an elongate channel lock member 324 which isoptionally removable from cap assembly 322, an outer sheath 326, aninner sheath 328 and an elongate flexible transmission member 330. Asseen in FIG. 44, cap assembly 322 further includes a fixedly attachedchannel lock receiver 332, an endoscope channel insert guide 334, anelongate tissue guard 336, an elongate needle guard 338 which extendsdistally from the base of the cap assembly and houses the mechanicalassembly that provides rotational motion for needle holder arm 340 asshown in FIG. 44. Channel insert guide 334 is a tubular projection fromcap assembly 322 and is adapted to be positioned within the lumen of anendoscope instrument channel at its distal end. The elongate flexiblechannel lock member 324 extends from the channel lock receiver 332through an instrument channel and is secured at the proximal end of theinstrument channel. The channel lock member 324 ensures that the capassembly 322 does not inadvertently disengage from the distal end of theendoscope. Preferably channel lock member 324 takes the form of a smalldiameter single or multi stranded wire or cable formed primarily ofmetals or polymers. Additionally the small diameter of channel lock 324allows room for other instruments to be positioned within the instrumentchannel of the endoscope. FIGS. 44 and 45 respectively show the capassembly 322 in a needle arm 340 closed configuration and a needle armopen configuration.

For purposes of example only, and not by way of limitation, in the shownembodiment, the cap assembly 322 has a cap or ring element 322 a havingan inner diameter of approximately 13.5 mm, an outer diameter ofapproximately 14.2 mm, a height of a little over 2 mm, and a portion 322b having a rim width of between 1 mm and 2 mm.

For purposes of example only, and not by way of limitation, in the shownembodiment, the elongate tissue guard 336 circumscribes approximately50° of the ring 322 a on its outside surface 336 a and extendsvertically approximately 9 mm over the top of the ring element 322 a atits middle portion. The inside surface 336 b of the elongate tissueguard 336 is generally semicircular (thereby helping define side walls336 d) and defines an approximately 4 mm-5 mm opening which extendsabove a smaller ring 322 c (see FIG. 48) of the cap assembly and above achannel of the endoscope into which the needle capture device (describedhereinafter with reference to FIGS. 55-57) is to be located. Thischannel may be the same channel of the endoscope into which the channelinsert guide 334 is inserted as described hereinafter. The top surface336 d of the elongate tissue guard 336 is angled at an approximately 45°angle. With the provided arrangement, and as discussed hereinafter withreference to FIGS. 63-39, the tissue guard 336 helps fold tissue forstitching and helps prevent tissue which is drawn into the cap assemblyfrom clogging the endoscope channel and preventing stitching.

For purposes of example only, and not by way of limitation, in the shownembodiment, the elongate needle guard 338 has a height of betweenapproximately 18 mm and 19 mm, and forms an arched opening between twoarms 338 a, 338 b which have outside surface spaced approximately 5 mmapart from each other and inside surfaces spaced approximately 3.7 mmfrom each other. The arms are joined by a top arch 338 c and an optionalcross-member (stop) 338 d located below the arch 338 c. In between thearms and below cross-member 338 d is a gear linkage 342 describedhereinafter. In addition, the curved needle holder arm 340 is arrangedsuch that when a needle is held in the needle holder arm 340, in a fullyopen position, the tip of the needle is preferably located under thearch 338 c and between the arms 338 a, 338 b. The holder arm 340 canthen rotate into a closed position through the arched opening above thegear linkage. Each arm 338 a, 338 b has a width of approximately 0.64 mmand a radial thickness of approximately 2.5 mm.

FIG. 46 shows a detailed exploded view of cap assembly 322. Needleholder arm 340 includes a first end 340 a which is adapted tofrictionally engage a needle assembly, and a second end 340 b is fixedlysecured to needle arm gear link 342 (e.g., in a receiving hole 342 adefined therein). By way of example only and not by way of limitation,needle holder arm 340 bends through an arc of approximately 90°. Gearlink 342 is mounted between needle guard arms 338 a, 338 b and includesa gear portion 344 which is mounted using pivot pin 345 through mountinghole 346 in gear link 342 to mounting holes (first mounting locations)347 defined in the housing (arms) of needle guard 338, and an arm orextension portion 343. Gear portion 344 includes lateral gear teeth 344a. Similarly, push member gear link 348 includes gear portion 350 a withlateral gear teeth 350 b which mesh with gear teeth 344 a, and an arm350 c. Gear link 348 is mounted using pivot pin 351 through mountinghole 352 to mounting holes (second mounting locations) 353 defined inthe housing (arms) of needle guard 338. Gear link 348 is also coupledthrough mounting hole 354 in arm 350 c to push member joint 356 usingpivot pin 357 and mounting bracket 358. Push member joint 356 is fixedlycoupled to transmission member 330. FIGS. 47 and 48 show cap assembly322 assembled where gear portion of gear link 348 intermeshes with gearportion of gear link 342 such that when transmission member 330 isadvanced gear link 348 rotates and its gear portion causes the gearportion of gear link 342 to rotate causing needle holder arm 340 to moveto a closed position. In the closed position, arm 343 of gear link 342extends around and above gear link 348 and between cross-member 338 dand arch 338 c. In the open position (FIG. 45), the arm 343 of gear link342 extends radially outward relative to needle guard arms 338 a, 338 b,and the back of the arm 350 c may engage the edge of cross-member 338 dwhich can act as a stop to gear movement.

Cap assembly 322 may also include a wash deflector 360 as shown in FIG.48. The wash deflector redirects fluid from the endoscope to wash thegear mechanism to remove debris. The aforementioned components are allpreferably made from biocompatible metals such as stainless steel andtitanium although some high strength polymers may be suitable. Thevertical positioning of mounting holes 347 and 353 in the needle guardarms 338 a, 338 b reduces the profile of cap assembly 322 andfacilitates delivery of the endoscopic suturing device 320 to atreatment site.

To aid in the retention of cap assembly 322 on the distal end of theendoscope FIGS. 49 and 50 illustrate views of cap assembly 322 wherechannel lock member 324 is optionally removably secured in channel lockreceiver 332 by channel lock retention member 362. Preferably retentionmember 362 is formed of a large bead fixedly secured to the distal endof channel lock member 324, whereas channel lock receiver 332 defines agroove 333 having a width smaller than the width of the bead. Ifdesired, the channel lock wire or cable 324 can be welded or otherwisefixed to the channel lock receiver 332 or to another part of the capassembly. An additional mechanism to increase the retention of the capassembly to the distal end of the endoscope is show in FIG. 50 where thechannel insert guide 334 has a partially split structure (i.e., one ormore longitudinal slits 335 are provided). The two portions of the splitmay be biased outwardly such that when they are placed in the instrumentchannel of the endoscope they apply and outward force to the inner wallof the channel thereby aiding in the retention of the cap assembly tothe distal end of the endoscope. FIGS. 51 and 52 show how tension isapplied to channel lock member 324 and maintained at the proximal end ofthe endoscope by using a channel lock tensioner 365 that secures theproximal channel lock retention member 366 secured to the proximal endof the channel lock member. The channel lock tensioner 365 includes abayonet lock connector 370, which couples to the endoscope instrumentchannel and a spring 372 which supports a tensioner housing 374 coupledto a rotatable tensioning wheel 376 having a tab member 378. Theproximal end of channel lock member 324 is threaded through tensionerhousing 374 and through a valve located at the top of the housing, andis positioned within a tab receptacle 380. The tab receptacle 380secures channel lock retention member 366 to the tensioner wheel 376.The tensioner wheel 376 can then be rotated (e.g., clockwise) to applythe appropriate tension on the channel lock member and then locked intoplace by a locking element (not shown). Spring 372 is used tocompensate, by compressing, for the bending of the endoscope to maintaina constant tension on the channel lock member. Alternatively, instead ofproviding a spring 372 between the bayonet lock 370 and the tensionerhousing 374, the spring can be provided on the wheel 376 to spring loadthe wheel toward a desired position (e.g., the position of FIG. 51). Asthe channel lock member 324 is bent along with the scope through atortuous path, wheel 376 can rotate against the force of the spring tomaintain the desired tension on the channel lock member 324.

FIG. 53 illustrates needle assembly 400 which comprises suture 402, aneedle tip 404, a lock gap 405 and a needle body 406. The suture 402 maybe formed of any materials commonly available for surgical suture suchas nylon, polyolefins, PLA, PGA, stainless steel, nitinol and others.FIGS. 54A through 54C show detailed exploded views of the components ofneedle assembly 400. Needle tip 404 has a sharp distal end and a hollowproximal end with a swage lip 408. Needle body 406 has a proximal endadapted to fit within the needle holder arm 340 and a distal end havinga suture slot 410. Needle body 406 is adapted to concentrically engageneedle tip 404 and create lock gap 405. Flexible suture material 402 ispositioned on the distal end of needle body 406 extending through thesuture slot 410. The needle tip 404 and needle body 406 are formed fromsuitable biomaterials and may be made from polymers such as nylon, PEEK,PLA, PGA, PLGA or metals such as stainless steel, nitinol or titanium.The components may be joined using standard joining techniques such asthermal bonding, ultrasonic welding laser welding, adhesives ormechanical crimping.

FIG. 55 illustrates a needle capture device 450, which includes anelongate catheter or tube 452 having at its distal end a needle captureassembly 454 and at is proximal end a button actuator 456 coupled tohandle assembly 458. By way of example only, and not by way oflimitation, the needle capture device 450 is a 3 mm tool in that thetube 452 and the distal end needle capture assembly 454 are preferablyat most 3 mm in diameter. The handle assembly 458 is preferably adaptedto be coupled to the handle assembly operating the needle holder arm ofthe endoscopic suturing device 320 for ease of use. Toward that end,handle assembly 458 is provided with a deflecting tooth lock 459 a and agenerally rigid tooth 459 b which are arranged to engage with reciprocalcavity and locking element in the handle assembly 600 of the suturingdevice 320 as discussed below with reference to FIGS. 58 and 59A-59C.

FIGS. 56A and 56B show an enlarged partial cross-sectional view ofneedle capture assembly 454 and the distal end 460 of tube 452 in closedand open configurations respectively. Slidably positioned within thelumen of tube 452 is push rod or cable 462 which has a proximal endmechanically coupled to button actuator 456 and a distal end coupled toactuator pin 464. Actuator pin 464 is positioned within an angled slot465 defined in lever arm 466 adjacent fixed pivot pin 468. At the distalend of lever arm 466 is an interlock feature 470. The distal innerportion of needle capture assembly 454 forms needle receptacle 472.Button actuator 456 incorporates a spring assembly which places push rod462 under a tension load thereby causing lever arm 466 to remain in anengaged or closed configuration as shown in FIG. 56A. When buttonactuator 456 is depressed, push rod 462 is advanced, there by causinglever arm 466 and interlock feature 470 to a disengaging or openconfiguration as shown in FIG. 56B. FIG. 57 illustrates needle assembly400 positioned within needle receptacle 472 of needle capture assembly454. As shown, needle assembly 400 is secured in place by theinterlocking engagement of interlock feature 470 and lock gap 405. Inthis configuration needle capture device 450 can be used to deliver theneedle through the instrument channel of the endoscope to load theneedle assembly into needle holder arm 340.

A handle assembly 600 for the endoscopic suturing device 320 is seen inFIGS. 58 and 59A-59C. The handle assembly 600 includes a firststationary handle 604 and a second rotatable handle 608 which isrotatably coupled to stationary handle by pivot axle 612. The rotatablehandle 608 is spring-biased to the open position seen in FIG. 58 by aspring 614 which sits and is fixed between the handles. The stationaryhandle 604 defines a proximal cavity 616 for receiving the handleassembly 458 of the needle capture device 450. Extending from thestationary handle 604 is a tube 618 which terminates in a port 620. Port620 includes a fluid valve 622 and a mechanical bayonet lock 624 forcoupling to the proximal end of an endoscope. Also extending from thestationary handle is sheath 328 which houses the transmission wire 330.Second handle 608 defines a fingers grip section 626, and ratchetedlocking element 628 at its proximal end. As described hereinafter, therotatable second handle 608 is coupled to the transmission wire 330.Movement of the rotatable handle towards the fixed handle causes axialmovement (retraction) of the transmission wire 330. Movement of therotatable handle away from the fixed handle causes axial movement(extension) of the transmission wire 330 in an opposite direction.

Turning now to FIGS. 59A-59C, additional details of the handle assembly600 are seen in addition to how the handle assembly 458 of the needlecapture device 450 interacts with the handle assembly 600 of theendoscopic suturing device 320. More particularly, as seen in FIG. 59A,pivotably coupled to the inside of first handle 604 by pivot pin 632 isan actuation pivot element 634. The transmission wire 330 is coupled tothe actuation pivot element 634 at a second location 636 by a spring 638which can move in a predetermined distance in a cavity 639 defined byfixed handle 604. The rotatable handle 608 is also coupled to theactuation pivot element 634 at a third location 640 by bracket 642 whichis coupled to the rotatable handle 608 by post 644. As a result,rotation of the handle 608 (i.e., squeezing) toward the closed positionof FIG. 59A causes bracket 642 to pull location 640 of the actuationpivot element 634 downward. Movement of location 640 downward in turn isaccompanied by clockwise rotation of the actuation pivot element 634about pivot pin 632, and thus backward (clockwise) movement of theconnection between spring 638 and the actuation pivot element 634 atlocation 636. Movement of spring 638 backward pulls transmission wire330 backward.

Also seen in FIG. 59A is the interaction of handle assembly 600 with thehandle assembly 458 of the needle capture device 450. More particularly,the stationary handle 604 is provided with a catch 648 which extendsinto cavity 616 and is designed to engage the flexible tooth (latch) 459a of the needle capture device handle assembly 458. In addition, cavity616 has a bottom proximal ledge 650 for receiving rigid tooth 459 b.Tube 618 which extends out of the stationary handle 604 extends into atubular cavity 654 of the stationary handle 604 which houses a spring656, thereby spring loading tube 618 outward.

When it is desired to extend the needle capture device 450 with itsdistal needle capture assembly 454 through the endoscope, the distal endof the needle capture assembly is threaded into cavity 616 of thestationary handle 604, tubular cavity 654, tube 618, port 620 and theninto the endoscope. The needle capture assembly 454 is pushed throughuntil the handle 458 engages the cavity 616 of the stationary handle604. When pushed as far as possible, rigid tooth 459 b aligns with ledge650, and flexible latch 459 a engages catch 648, thereby locking theneedle capture device 450 in place. Cable 462 of the needle capturedevice 450 with sheeth 452 extends from the button actuator 457 throughthe tubular cavity 654, through the tube 618, and through and out of theport 620. To actuate the needle capture assembly, button 456 is pushedas previously described. Disconnection of the needle capture device 450from the handle assembly 600 is obtained by pressing down on a relievedportion 459 c of the handle 458 adjacent and proximal the latch 459 a,thereby causing the latch to disengage from the catch 648, and pullingproximally on the handle 458.

As seen best in FIGS. 59B and 59C, the needle capture device handle 458is preferably provided with a ratchet locking extension or (hooked)tooth 459 d. When the needle capture assembly 450 is in place in thehandle 600 assembly of the endoscopic suturing device, the handles 604and 608 may be locked into place in a closed position by engagingratcheted locking element or tooth 628 on rotatable handle 608 with thesimilar ratcheted locking extension or tooth 459 d of the needle captureassembly 450 (which in turn is locked in stationary handle 604) as seenbest in FIG. 59C. As will be appreciated, the teeth 628 and 459 d aregenerally laterally offset, but include hooked portions which aftersliding past each other, will engage or grip each other, thereby lockingin place. Disengagement is obtained by applying a relative lateral forceto one or both of the handles.

An innovative suture dispenser 500 having a dispenser body 502 and aremovable needle shield tab 504 is shown in FIG. 60A. The suturedispenser 500 is shown in FIG. 60B with the needle shield tab 504removed from the dispenser revealing a needle retaining member 506. Tobetter illustrate the suture dispenser 500, FIG. 60C shows an explodedperspective view of the components. Suture dispenser 500 includes alower body 508 and upper body 510 which together form a cavity whichhouses suture spool 512 containing suture 402, needle shield 504 andneedle retaining member 506. The lower and upper bodies 508, 510preferably include ribs 508 a, 508 b (similar ribs on upper body notshown) on and about which spool 512 rests so that spool 512 can rotatewith a minimum of friction in the cavity. The lower and upper bodies508, 510 are also each preferably provided with walls 513 a, 513 b, 513c (seen in FIG. 60C only with respect to lower body 508) which retainthe needle retaining member 506 in place but permit the needle shieldtab 504 to be removed. More particularly, wall 513 a is seen to form aback wall for the needle retaining member. It includes a cutout ororifice 513 d for receiving a rear portion of the needle retainingmember (and needle) and it angles at 513 e to join outer wall 513 c.Wall 513 b is a low wall which is placed in between walls 513 a and 513c and is connected to the angled portion 513 e of wall 513 a. Wall 513 beffectively forms two grooves with the first groove seating the needleretaining member 506 and holding it in place and the second grooveseating a portion of the needle shield tab 504. Needle shield tab,however extends out of a radial opening or orifice in outer wall 513 cand can be pulled out (i.e., can slide out) completely to reveal areceiving cavity 514 in the needle retaining member 506. The outer wall513 c is also provided with an opening or orifice 513 f in front of thereceiving cavity 514. The suture dispenser 500 and most of itscomponents are easily fabricated at low cost using suitable polymers,such as polyethylene, polypropylene or polystyrene, injection moldingand preferably designs which snap together (e.g., latches 508 c andhollow receiving post 508 d on lower body 508, and catches 510 c andpost (not shown) on upper body 510).

As seen in FIG. 60B, needle shield 504 is preferably provided withprongs 504 a. The prongs are squeezably held between ribs (not shown)extending from the lower and upper bodies 508, 510 in order to hold theneedle shield 504 in place. However, because the prongs are resilient,application of force to the tab portion 504 b of the needle shield 504,permits the needle shield 504 to be removed from the dispenser body 502.

As previously mentioned, needle retaining member 506 includes a needlereceiving cavity 514 as shown in FIGS. 61A and 61B where removableneedle assembly 400 is held. As shown in the partial cross-section viewof FIG. 61B, needle body 406 is frictionally held within an orifice 514a defined in the body of retaining member 506 (in much the same mannerit is frictionally held in the needle holder arm 340 (FIG. 46) and theneedle is connected to suture 402 which is wound on the suture spool.Needle tip 404 is accessible to the needle capture assembly 454 throughneedle receiving cavity 514; i.e., the cavity provides room around theneedle tip to permit the needle capture assembly to enter the cavity andgrab the needle. Also as shown in FIG. 61B, the needle retaining member506 has laterally elongated upper and lower flanges 514 b which arereceiving and seat in the grooves formed by the walls 513 a, 513 b ofthe lower and upper bodies 508, 510 of the suture dispenser 500. Thebody of the needle retaining member has a cylindrical portion whichextends backward through the orifice 513 d of the inner wall 513 a.

FIGS. 62A and 62B show the suture dispenser 500 receiving the needlecapture assembly 454 of needle capture device 450. FIG. 62B shows apartial cross section view of the needle capture assembly 454interlockingly engaged with the needle for removal from the dispenser.

FIG. 63 through FIG. 69 depicts a method of performing a suturingoperation using an endoscopic suturing device 320 of the presentinvention. As shown in FIG. 63, the endoscopic suturing device 320 ispositioned adjacent tissue 154 which has a tissue defect 156 to beclosed. The endoscopic suturing device 320 is in an open configurationand the tip of needle assembly 400 is shrouded by needle guard 338. FIG.64 shows the tissue grasper 26 is extended from the endoscope instrumentchannel such that helical tip 42 is adjacent tissue defect 156. Rotationof the tissue grasper 26 causes the helical tip 42 to securely engagethe tissue 154 adjacent to the tissue defect 156. The tissue 154 may bebrought closer to the endoscope by slightly retracting the tissuegrasper 26 into the instrument channel of the endoscope as shown in FIG.65. During the retraction of tissue, the needle guard 338 prevents thetissue from dragging against the tip of needle assembly 400, therebyreducing inadvertent tissue damage. The degree of tissue retractioncorrelates to the size and location of the stitch. For instance to havea larger amount of tissue sutured, the tissue grasper may bring thetissue 154 close to the endoscope as shown in FIG. 66. When attemptingto suture a large amount of tissue, the position of the angled distalend of tissue guard 336, in conjunction with the needle guard 338, aidsin folding the tissue in preparation for suturing and preferably aids inpreventing the tissue from locating immediately adjacent and therebyclogging the needle capture device. The needle holder arm 340 isactuated to move to a closed position causing the needle assembly 400 topierce tissue 154. The angled portion of tissue guard 336 providessupport for the tissue allowing the needle to more easily penetrate thetissue as shown in FIG. 67. The suture 402 is pulled through the tissueas shown in FIG. 68. The control over the amount of tissue retractedallows the physician the ability to perform a partial thickness stitchwithin the wall of a tissue or a full thickness stitch which extendsthrough a wall of tissue. The needle capture device captures the needleassembly 400 and removes it from the needle holder arm 340(not shown).FIG. 69 shows the needle holder arm 340 moved to an open configurationand removed from tissue 154. Suture 402 remains through the tissue. Tocontinue a running stitch, the needle holder arm can be reloaded withthe needle assembly without needing to remove the endoscopic suturingdevice from the body as previously described. If only one stitch isrequired the suture may be tied into a surgical knot or a cinch deviceused to secure the suture, thereby closing the tissue defect.

The present invention has been described in conjunction with thepreferred embodiments shown in various drawings. Obviously, however,other similar embodiments can be used to realize the same functions asthose of the present invention, the above embodiments can be modified,or other embodiments can be added. The present invention is nottherefore limited to any single embodiment. For example, each treatmentdevice described above can be used together with a rigid endoscope,trocar, or the like as well as flexible endoscopes. Also, whileparticular sizes and shapes were described with respect to the end cap,needle guard, tissue guard, etc. of a particular embodiment, other sizesand shapes could be utilized. For purposes of understanding thespecification and claims, where the terms “substantially” or“approximately” are used, they should be understood to provide a rangeof plus or minus 20%, For example, an angle of “approximately 180degrees” should be understood to include an angle in the range of 144 to216 degrees. A size of “substantially 2 mm” should be understood toinclude a size in the range of 1.6 to 2.4 mm. Further, it should beappreciated that different aspects of each embodiment can be used inconjunction with the other embodiment. By way of example only, thehandle assemblies for the needle capture device and for the endoscopicsuturing device described with reference to FIGS. 55 and 58-59C, can beused in conjunction with the needle capture device and endoscopicsuturing device of the first embodiment (FIG. 1). It will therefore beappreciated by those skilled in the art that yet other modificationscould be made to the provided invention without deviating from itsspirit and scope as claimed.

1.-71. (canceled)
 72. A method of suturing tissue of a mammal using anendoscopic suturing system, comprising the follow steps: (a) inserting aguide tube and/or endoscope into a body with a suturing device coupledto the endoscope and or guide tube; (b) opening a needle arm of thesuturing device having a removable needle; (c) pushing the needleagainst tissue at a desired suture site; (d) closing the needle arm ofthe suturing device; (e) piercing the tissue with the needle; (f)recovering the needle by using a needle capture device; (g) removing theneedle from the tissue; (h) opening the needle arm to remove it fromtissue; (i) closing the needle arm; and (j) removing the suturing devicefrom the body.
 73. A method according to claim 72, further comprising:after step (b) and before step (c), engaging a tissue adjacent a desiredsuture site using a tissue grasper; and after step (h) and before step(i), releasing the tissue from the tissue grasper.
 74. A methodaccording to claim 72, further comprising: (k) after step (i) and beforestep (j), inserting the needle into the needle arm endoscopically usingthe needle capture device; and repeating steps (b) through (i) and (k)as needed.
 75. A method of suturing tissue of a mammal using anendoscopic suturing system, comprising the follow steps: (a) inserting aguide tube into a body; (b) inserting a suturing device coupled to theendoscope into the guide tube and inserting the suturing device into thebody; (c) opening a needle holding arm of the suturing device having aremovable needle clip; (d) engaging a tissue adjacent a desired suturesite using a tissue grasper; (e) pushing the needle clip against tissueat a desired suture site; (f) closing the needle holding arm of thesuturing device; (g) piercing the tissue with the needle clip; (h)grasping the needle clip tip using a needle capture device; (i) openingthe needle holding arm to remove it from tissue; (j) releasing theneedle clip from the needle capture device; (k) releasing the tissuefrom the tissue grasper; (l) closing the needle holding arm; and (m)removing the suturing device from the body.
 76. A method according toclaim 75, wherein: the tissue grasper includes a helical coil with asharp distal tip that is rotated into the tissue to engage the tissue.77. A method according to claim 75, wherein: said engaging tissueincludes rotating the tissue grasper relative to the tissue.
 78. Amethod according to claim 75, further comprising: after opening theneedle arm, releasing the tissue grasper from the tissue.
 79. A methodaccording to claim 78, wherein: said releasing includes rotating thetissue grasper relative to the tissue.
 80. A method of suturing tissueof a mammal using an endoscopic suturing system, comprising the followsteps: (a) inserting a guide tube and/or endoscope into a body with asuturing device coupled to the endoscope and or guide tube; (b) openinga needle arm of the suturing device having a removable needle; (c)engaging a tissue adjacent a desired suture site using a tissue grasper;(d) drawing the engaged tissue into the path of the needle; (e) closingthe needle arm of the suturing device to cause the needle to pierce thetissue; (f) engaging the needle with a needle capture device passedthrough the guide tube and/or endoscope; (g) removing the needle fromthe tissue; (h) opening the needle arm; (i) closing the needle arm; and(j) removing the suturing device from the body.
 81. A method accordingto claim 80, wherein: the tissue grasper includes a helical coil with asharp distal tip that is rotated into the tissue to engage the tissue.82. A method according to claim 80, wherein: said engaging tissueincludes rotating the tissue grasper relative to the tissue.
 83. Amethod according to claim 80, further comprising: after opening theneedle arm, releasing the tissue grasper from the tissue.
 84. A methodaccording to claim 83, wherein: said releasing includes rotating thetissue grasper relative to the tissue.